13485 certification

The standard is based on the ISO 9001 standard, increased the special requirements of the medical equipment industry, formulated, that is, the so-called 1+1 standards. Therefore, the ISO 13485 standard meets the requirements of ISO 9001 standard. After the promulgation of the ISO 9001:2008 standard, ISO/TC 210 issued a new ISO 13485:2003 standard.

The new standard is no longer a guideline for the implementation of the ISO9001 standard in the medical device industry, neither of which is compatible. New standard 1.1 general principles: "the main purpose of this standard is to facilitate the implementation of harmonized regulatory requirements for quality management systems.". Therefore, this standard contains specific requirements for some medical devices and cuts down some requirements in ISO 9001 that are not suitable for regulatory requirements. Because of these exclusions, the quality management system that meets this standard cannot claim compliance with the ISO 9001 standard unless its quality management system meets all the requirements of ISO 9001. "

According to the characteristics of the medical device industry, the new standards require documented procedures, operating instructions or requirements.

1. file control program (4.2.3).

2. record control program (4.2.4).

3. training (6.2.2).

Note: national or regional regulations may require organizations to establish procedures for identifying documentation of training needs.

4. maintenance of infrastructure (when maintenance activities or the lack of such maintenance activities may affect the quality of the product, the organization shall establish documented maintenance activities requirements, including their frequency).

5. work environment (6.4).

When a person's contact with a product or work environment can adversely affect the quality of the product, the organization shall establish documented requirements for the health, cleanliness and clothing of the personnel;

If the working conditions have adverse effects on the quality of the product, the organization shall establish documented working conditions, requirements and procedures or operating instructions to monitor and control these working conditions;

Where appropriate, in order to prevent contamination of other products, work conditions or personnel, the organization shall establish special arrangements for the formation of documents for the control of contaminated or easily contaminated products.

6. risk management (7.1).

The organization shall establish the requirements for the formation of risk management documents throughout the product realization process. Records of risk management shall be maintained.

7. product requirements (7.2.2).

Product requirements are specified and documented.

8. design and development program (7.3.1).

The outputs of the design and development plan shall be documented.

9. purchasing process (7.4.1).

10. control of production and service provision.

When necessary, obtain documented procedures, documentation requirements, job instructions, and reference materials and referenced measurement procedures (7.5.1.1b).

Requirements for documentation of product cleanliness and pollution control (7.5.1.2.1).

Requirements for the establishment of acceptance criteria for medical equipment installation and installation (7.5.1.2.2).

Service providing activities and their verification procedures, operating instructions, reference materials and measurement procedures (7.5.1.2.3).

11. computer software validation procedures and sterilization process validation procedures (7.5.2.1).

12. product identification program (7.5.3.1).

13. traceability procedures (7.5.3.2.1).

14. product protection procedures or operation instructions (7.5.5).

15. monitoring and measuring device control program (7.6).

16. feedback system procedures to provide early warning of quality problems and to input corrective and preventive action procedures (8.2.1)

17. internal audit process (8.2.2).

18. product monitoring and measurement program (8.2.4.1).

19. nonconforming product control procedure (8.3).

20. data analysis program (8.4).

21. Advisory notice release and implementation procedures (8.5.1).

Report the incident to the administrative department (when required by law).

22. corrective action procedures (8.5.2).

23. preventive action procedures (8.5.3).

According to the industry characteristics of medical equipment, the new standard has made many professional regulations.

1. 4.2.4 record control stipulates: "the life of medical organization record keeping period shall be at least equivalent to the provisions of the organization, but the release of the product from the organization's date not less than 2 years, according to the relevant laws and regulations or requirements. "

2. the responsibilities and authority of the 5.5.2 management representative, c) require that "ensure that the awareness of meeting regulatory requirements and customer requirements is enhanced throughout the organization". "

3. 5.6.2 management review input adds "H" new or revised regulatory requirements. "

4., 6.4 work environment increased the product cleaning, pollution prevention, health and other aspects of the requirements.

5., 7.1, the product realization plan has increased the risk management content.

6. 7.2.3 customer communications increased the "d" Notice of advice. "

7. 7.3.1 design and Development Planning B) pointed out that "the design and development stages, the review, verification, validation and conversion design activities (Note: the design and development process design transformation activities can ensure that the design and development outputs in the final product specification before become verified, to ensure that it is suitable for manufacturing). "

8., the 7.3.2 design and development input a is changed to "function, performance, and safety requirements as intended" and adds "e" to risk management output. "

9. the 7.3.3 design and development output adds "records that should maintain design and development outputs" (Note: records of design and development outputs may include specifications, manufacturing procedures, engineering drawings, engineering or research process records)".

10. 7.3.4 design and development review participants increased the number of other experts. "

11. 7.3.5 design and development validation